The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of Parkinson's Disease (PD) * Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD * Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate treatment. This study is designed as a prospective, single-site, single arm, nonrandomized study. Assessments will be made before and three months after MRgFUS for clinical symptom relief, quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue, including functional brain targets. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images, and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment, an ultrasound transducer generates a point of focused ultrasound energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, enabling neurophysiological assessment in the low range, and thermal coagulation at higher ranges. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the affected region.
Department of Neurosurgery, Yonsei University College of Medicine
Seoul, South Korea
the unified dyskinesia rating scale (UdysRS) and UPDRS part IV
Dyskinesia will be assessed for each treated PD patient using the UDysRS and UPDRS part IV at baseline before treatment and at post-treatment intervals: 1 week, 1 month, and 3 months, 6 months and 12 months. The validated rating assessment of dyskinesia will be administered by a movement disorder neurologist or physical therapy specialist in an outpatient clinic setting. The primary measure utilized in this protocol will be a reduction in the contralateral upper extremity. Additionally, a total/overall dyskinesia score will be obtained for each patient at each time interval by summing the appendicular and axial scores.
Time frame: 3 months after treatment
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